1. OHRP’s Compliance Oversight Procedures
Kristina C. Borror, Ph.D.
Division of Compliance Oversight
Office for Human Research Protections

2. Presentation Overview
OHRP compliance oversight activities
Common areas of noncompliance identified by OHRP
Underlying causes of noncompliance
Solutions to correct/prevent noncompliance

3. OHRP’s Jurisdiction Research conducted or supported by HHS
Research conducted at an institution holding an applicable Assurance of Compliance

4. OHRP Compliance Oversight Activities

5. Compliance Oversight Investigation
Receive allegation of noncompliance
Determine OHRP jurisdiction
Written inquiry to appropriate institutional officials
Review of institution report and relevant IRB documents
Additional correspondence/telephone interviews/site visit as needed
Issue final determinations

6. For-Cause Site Visits When does OHRP conduct a site visit? Based on:
nature and severity of the allegations
evidence of systemic problems
appropriateness of any corrective actions taken
perceived need for more in-depth discussions with institution staff

7. For-Cause Site Visits Interviews with-- institutional administrator(s)
IRB Chairperson(s)
IRB members
IRB staff
investigators who conduct human subjects research
others as appropriate

8. For-Cause Site Visits Record Reviews
OHRP selects active protocols for review of entire IRB record on-site
last 25 protocols approved by the IRB under an expedited review procedures
last 25 amendments approved by the IRB under an expedited review procedure
Protocols determined to be exempt during the past 6 months
minutes for all IRB meetings for last 4 years

9. For-Cause Site Visits Findings
Meet with the signatory officials on the Assurance, or their designees on last day to describe OHRP’s findings

10. Compliance Oversight Investigation Possible Determinations/Outcomes (1)
Protections under an institution’s Assurance are in compliance
Protections under an institution’s Assurance are in compliance, but recommended improvements have been identified
Noncompliance identified, and corrective actions required
Noncompliance identified, and Assurance restricted pending required corrective actions

11. Compliance Oversight Investigation Possible Determinations/Outcomes (2)
Noncompliance identified, and OHRP approval of Assurance withdrawn
OHRP may recommend to appropriate HHS Officials or PHS agency heads that:
an institution or investigator be temporarily suspended or permanently removed from participation in specific project
peer review groups be notified of an institution’s or an investigator’s past noncompliance prior to review of new projects

12. Compliance Oversight Investigation Possible Determinations/Outcomes (3)
OHRP may recommend that institutions or investigators be declared ineligible to participate in HHS-supported research (Debarment). Debarment will be initiated in accordance with procedures specified at 45 CFR Part 76.

13. Common Areas of Noncompliance Identified by OHRP

14. Common Areas of Noncompliance (1)
OHRP Compliance Activities: Common Findings and Guidance - 7/10/02
Borror et al, “A Review of OHRP Compliance Oversight Letters.” IRB: Ethics and Human Research. Sept-Oct 2003; Vol 25 No 5: 1-4.

15. Common Areas of Noncompliance (2)
Initial and continuing IRB review
Expedited IRB review procedures
Reporting of unanticipated problems
IRB review of protocol changes
Informed consent
IRB membership, expertise, staff, support, and workload
Documentation of IRB procedures, activities, and findings

16. Common OHRP Findings Initial and Continuing IRB Review
Insufficient information to make determinations required under 45 CFR
Inadequate review at convened meetings
No substantive continuing review
Failure to conduct continuing review at least annually
Lack of quorum at convened meetings
Research conducted without IRB review

17. Common OHRP Findings Expedited Review
Inappropriate use of expedited review for initial and continuing review
Inappropriate use of expedited review for protocol modifications
Failure to advise full IRB of expedited approvals

18. Common OHRP Findings Informed Consent
Failure to include all required elements of informed consent [45 CFR (a)]
Failure to include additional elements of informed consent when appropriate [45 CFR (b)]
Underestimation of risks/overestimation of potential benefits
Language too complex
Exculpatory language

19. Common OHRP Findings IRB Membership, Expertise, Support
Lack of diversity of IRB membership
Lack of IRB expertise regarding research with children
Lack of prisoner/prisoner representative on IRB for review of research with prisoners
IRB Chair/members lack sufficient understanding of HHS regulations
Inadequate resources

20. Common OHRP Finding IRB Policies, Procedures and Findings (1)
Inadequate IRB records
Inadequate IRB minutes
Failure of IRB to consider additional safeguards for vulnerable subjects
Failure of IRB to make required findings when reviewing research involving children

21. Common OHRP Finding IRB Policies, Procedures and Findings (2)
Failure of IRB to make and document required findings for waiver of informed consent
Failure to make required findings for IRB waiver of a signed informed consent document
Lack of appropriate written IRB policies and procedures

22. Underlying Causes of Noncompliance

23. Underlying Causes of Noncompliance
Inadequate education of IRB members, IRB staff, and investigators
Inadequate staff and resources for the IRB
Overburdened IRBs

24. Solutions to Correct/Prevent Noncompliance
Education
Adequate IRB staff and resources
Adequate number of IRBs
Adequate IRB documentation (in particular, adequate minutes of IRB meetings)
Periodic self-assessment of institutional system for protecting human subjects